MAUDE Adverse Event Report: BUSSE HOSPITAL DISPOSABLES, INC. POST MORTEM KIT; GENERAL SURGERY TRAY

Catalog Number 901

Device Problems Product Quality Problem (1506); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/16/2019

Event Type  malfunction  

Event Description

We have been experiencing problems with body bags for a few years.They are ripping.My uniform got contaminated so bad that i had to completely change my uniform.

• Brand Name: POST MORTEM KIT
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): BUSSE HOSPITAL DISPOSABLES, INC.; 75 arkay dr.; hauppauge NY 11788
• MDR Report Key: 8703651
• MDR Text Key: 148165836
• Report Number: 8703651
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1